
THE
CLINICAL
DATA
STORY
155
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
As clinical case report forms are retrieved from study centers, they are reviewed
by the Clinical Monitor and Clinical Research Associate prior
to
being forwarded
to
the Clinical Data Processing Group.
A copy of the original case report form is supplied to the Clinical Data Coder (CDC)
for review and classification prior
to
computer entry. The Clinical Data Coder
classifies information
on
the case report form for consistency in reporting.
Information such as clinical side effects and concomitant medications are
classified using one of many available classification dictionaries.
The case report form is keyboard entered and verified prior
to
transmission to
storage in the clinical study database. A screen of edits is imposed on the data
prior
to
database inclusion
to
avoid “uncleansed” data being combined with
lnedically cleansed data.”
As data further matures in our process, it is moved into the clinical database for
the study.
The Registration Lock Date (RLD) is another milestone in our process. This is the
last day in which
a
patient may be enrolled for inclusion in the clinical study.
At predetermined intervals, “intelligent” edits are circulated and reviewed by the
Medical Monitor, Statistician, and Medical Writer. Corrections are noted on the
edit report and the process continues.
Iferrors are identified in the edit reports, reprocessing of Steps
4.2,4.3,4.4
and
4.6
will
occur.
Ifno
errors are identified, Step
4.8
will occur.
The Data Lock Date (DLD) is a milestone that identifies the last day a case report
form will be accepted for inclusion in the clinical study database.
Final cleanup of the database is taking place and if no errors are identified, the
process proceeds to
4.10
database lock.
The
database lock is a milestone in which the Study Monitor, Study Statistician
and Medical Writer agree that
no
further changes to the database will be made.
V.
CLINICAL DOCUMENT PREPARATION
5.1
Final databases are now released for use by all study personnel and the following
documents for the New Drug Application are prepared.
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